- For the first quarter 2024, Celularity expects combined net sales of $14.8 million for its advanced biomaterial product and biobanking businesses, compared to the $10.25 million to $11.5 million guidance range previously announced in February.
- Celularity’s expected combined net sales for the first half 2024 are $25.8 to $27.8 million compared to $6.9 million of net sales in the first of 2023 at the midpoint of the 2024 range.
- Celularity reiterated it is on track to file a 510(k) premarket submission for its Celularity Tendon Wrap in the second half 2025, the first of three planned advanced biomaterial medical devices.
FLORHAM PARK, N.J., July 31, 2024 (GLOBE NEWSWIRE) — Celularity Inc. (Nasdaq: CELU) (“Celularity”) a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, today announced its 2023 full-year reported combined net sales of its advanced biomaterial product and biobanking businesses and announced first half 2024 expected combined net sales. As used here, “net sales” refers to direct-customer and distributor product sales of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as fees or revenue earned under research collaboration agreements.
As reported on its Form 10-K for the year ended December 31, 2023, Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $22.8 million for the full year 2023, consisting of advanced biomaterial product net sales of $17.3 million and biobanking net sales of $5.4 million. Reported full year 2023 combined net sales of $22.8 million represents an increase of 26.7% over full year 2022 reported combined net sales and is slightly above the high end of the expected full year 2023 combined net sales range of $22.06 million to $22.76 million announced in January.
Full-year 2023 reported combined net sales is inclusive of the fourth quarter 2023, in which Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $12.1 million, consisting of advanced biomaterial product net sales of $10.7 million and biobanking net sales of $1.4 million. Reported fourth quarter combined net sales of $12.1 million are also at the high end of the expected net sales range of $11.4 million to $12.1 million announced in January.
Celularity also updated its expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the second quarter 2024, respectively. For the first quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $14.8 million compared to the guidance range of $10.25 million to $11.5 million announced in February, consisting of expected net sales for its advanced biomaterial product business of $13.5 million and expected net sales for its biobanking business of $1.3 million. For the second quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $11.0 to $13.0 million, consisting of expected advanced biomaterial product net sales of $10.0 to $11.5 million and expected biobanking net sales of $1.0 to $1.5 million. For the first half of 2024 combined, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses between $25.8 and $27.8 million.
“At this midpoint of 2024, we believe Celularity is on a positive revenue trajectory, building on the very strong net sales growth we reported for 2023,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder of Celularity. “The significant increase in our net sales reflects the growing demand for our advanced biomaterial products and biobanking services. While we are encouraged by our progress, we recognize the financial challenges impacting the industry.”
Dr. Hariri continued, “As we navigate the second half of 2024, we are committed to expanding our market presence, enhancing our product offerings, and implementing further strategic measures to improve our financial stability. Our team’s relentless dedication to innovation and operational excellence has enabled us to exceed our financial targets, yet we must remain vigilant in managing our resources effectively. We believe that by maintaining a balanced approach, we can continue to drive long-term value for our shareholders while navigating the complexities of our financial landscape.”
Celularity’s advanced biomaterial product portfolio consists of four commercial-stage products and three development pipeline product candidates. Celularity’s commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices marketed primarily under its own brands in the U.S. for use in soft tissue repair and reconstructive procedures, including acute and chronic non-healing wounds and burns:
- Biovance®, a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair and reconstructive procedure.
- Biovance®3L, a tri-layer human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites and to support the treatment of ocular surface disease and ocular surgical applications.
- Interfyl®, a decellularized human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.
- CentaFlex®, a decellularized human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissues.
Celularity’s advanced biomaterial product developmental pipeline includes human placental tissue derived medical devices that are intended to treat aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues, including:
- Celularity Tendon Wrap, a scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use in the management and protection of tendon injuries.
- Celularity Bone Void Filler, a moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
- Celularity Placental Matrix, a resorbable device composed of extracellular matrix derived from decellularized human placental tissue that Celularity is developing for use as a passive temporary wound covering.
About Celularity
Celularity Inc. (NASDAQ: CELU) is an innovative regenerative and cellular medicine company. It is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. What sets Celularity apart is its therapeutic programs that target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity’s unique approach, harnessing the placenta’s biology and ready availability, is paving the way for therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include statements regarding: (i) our 2023 sales and sales growth relative to prior periods; (ii) our expected 2024 sales and sales growth relative to prior periods; (iii) our future sales or sales growth; (iv) our 2024 financial goals and expectations for future financial results, including levels of net sales; (v) our expectations regarding our new products; and (vi) demand for our products. Forward-looking statements include all statements that are not historical facts and all statements relating to future events, including expectations regarding our operational and efficiency initiatives, our strategy, expected net revenue per unit, forecasted results, and expectations regarding the effect of our actions to improve performance. These forward-looking statements reflect our current expectations and projections with respect to, among other things, the Company’s financial condition, results of operations, plans, objectives, strategy, future performance, and business. In some cases, you can identify forward-looking statements by terminology that may precede, follow or include the words “aim,” “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “likely,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “project,” “projection,” “seek,” “should,” “strive,” “target,” “will,” “would,” “will,” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning.
The forward-looking statements in this press release are subject to risks and uncertainties and we caution against placing undue reliance on such statements. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: our future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment, and many other factors beyond our ability to control; we may change our plans due to unforeseen circumstances; the regulatory status of our advanced biomaterial products; our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; our ability to sell our advanced biomaterial products in other countries depends on a number of factors including the local reimbursement environment, the regulatory status of our advanced biomaterial products, and our ability to establish and manage a third party distribution relationships; the risks associated with our current liquidity as well as developments relating to our competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on July 30, 2024, and other filings with the SEC.
If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know, or that we currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect our current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we undertake no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Investor Contact:
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
Media Contact:
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
rcona@kcsa.com / mfawcett@kcsa.com
